Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer

Not Applicable

Completed

Conditions: Breast Cancer

Registration Number: NCT00005957

Lead Sponsor: NCIC Clinical Trials Group

Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer.

Detailed Description: OBJECTIVES:

* Compare the overall survival, disease-free survival, isolated local regional disease-free survival, and distant disease-free survival in women with previously resected, early stage, invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy.

* Compare the toxic effects of these regimens in these patients.

* Compare the quality of life of patients (in certain participating centers) treated with these regimens.

* Compare the cosmetic outcomes in patients (in certain participating centers) treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs more than 3), number of axillary nodes removed (\<10, \> or equal to 10); type of chemotherapy (anthracycline containing vs other vs none), hormonal therapy (yes vs no), number of axillary lymph nodes excised\*, and participating center. Patients are randomized to one of two treatment arms.

NOTE: \* Patients with a negative sentinel node dissection with or without an axillary dissection will be stratified according to the total number of nodes removed

* Arm I: Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

* Arm II: Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

Radiotherapy in both arms begins as soon as possible after randomization. Radiotherapy must begin within 8 weeks after completion of adjuvant IV chemotherapy, unless radiotherapy is administered concurrently with chemotherapy (i.e., cyclophosphamide, methotrexate, and fluorouracil \[CMF\]), or within 16 weeks after the last breast surgery for patients treated with hormonal therapy alone.

Quality of life is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 and 9 months after completion of radiotherapy, and then annually until first distant disease recurrence.

Cosmetic outcome is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, and then at 3 and 5 years after completion of radiotherapy or until first distant disease recurrence.

Patients are followed at 3, 6, and 9 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 1,822 patients will be accrued for this study within approximately 4 years.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1832

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Survival	10 years	Duration of study

Secondary Outcome Measures

Name	Time	Method
Disease-free Survival	10 years	Disease-free survival (including locoregional and distant disease)

Trial Locations

Locations (26): Tom Baker Cancer Centre
🇨🇦
Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦
Edmonton, Alberta, Canada
BCCA - Fraser Valley Cancer Centre
🇨🇦
Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre
🇨🇦
Vancouver, British Columbia, Canada
BCCA - Vancouver Island Cancer Centre
🇨🇦
Victoria, British Columbia, Canada
CancerCare Manitoba
🇨🇦
Winnipeg, Manitoba, Canada
The Vitalite Health Network - Dr. Leon Richard
🇨🇦
Moncton, New Brunswick, Canada
Atlantic Health Sciences Corporation
🇨🇦
Saint John, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦
St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Center
🇨🇦
Halifax, Nova Scotia, Canada
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Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada